DIABETIC TUSSIN COUGH DROPS- menthol lozenge 
Health Care Products

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each cough drop)

Menthol 5.8 mg

Purpose

Cough suppressant/Oral anesthetic

Uses

temporarily relieves:

  • coughs as may occur with a cold or inhaled irritants
  • occasional minor irritation and sore throat

Warnings

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. These symptoms may be serious.

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

When using this product

  • do not exceed recommended dosage

Stop use and consult a doctor if

  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore throat is severe, or irritation, pain or redness lasts or worsens
  • sore mouth does not improve in 7 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep this and all drugs out of the reach of children.

Directions

adults & children 3 years & over:allow 1 drop to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor.
children under 3 years:ask a doctor

Other Information

  • 6 calories per drop
  • Phenylketonurics: contains phenylalanine 2 mg per drop.
  • product may be useful for diabetics on the advice of a doctor.
  • Dietary Exchange* information:

    1 Drop = FREE Exchange

    10 Drops = 1 Fruit

    * The dietary exchanges are based on the Exchange List for Meal Planning, ©1995 American Diabetes Association and the American Dietetic Association.

Inactive Ingredients

acesulfame potassium eucalyptus oil, flavoring hydrogenated starch hydrolysate, isomalt, sucralose and water. Soybean oil used as a processing aid.

Questions or comments?

Call: 1-800-899-3116, Mon-Thurs. 9:00 am - 5:00 pm EST, Fri. 9:00 am - 2:30 pm EST.

Serious side effects associated with use of this product may be reported to this number.


Rev. 058:05 4/09

Package/Label Principal Display Panel

Image of Bag

Diabetic Tussin® brand

COUGH DROPS

COUGH SUPPRESSANT/ORAL ANESTHETIC

MENTHOL EUCALYPTUS

Controls Coughs And Soothes Sore Throats

 

 COMPLETELY SUGAR FREE!

 

25 COUGH DROPS

DIABETIC TUSSIN COUGH DROPS 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61787-058
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5.8 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
EUCALYPTUS OIL 
ISOMALT 
SUCRALOSE 
WATER 
SOYBEAN OIL 
Product Characteristics
ColorWHITE (colorless to opaque) Scoreno score
ShapeOVALSize23mm
FlavorMENTHOLImprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61787-058-2525 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/03/200104/30/2014
Labeler - Health Care Products (101196749)
Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
NameAddressID/FEIBusiness Operations
BestSweet Inc002149136MANUFACTURE(61787-058)

Revised: 7/2011
Document Id: 98523a35-7e1e-4c58-8a4b-62b0bdcf1b9a
Set id: eb9a9f9c-4dec-4791-bb1b-939a736f201b
Version: 2
Effective Time: 20110729
 
Health Care Products